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Alcami will manufacture clinical supply of the API for a drug candidate targeting various hematologics and solid cancers.
On Nov. 9, 2017, Alcami, a contract development and manufacturing organization, announced manufacturing and quality agreements with Solasia Pharma, a Japanese specialty pharmaceutical company based in Asia, to manufacture clinical supply of darinaparsin, the active pharmaceutical ingredient (API) in a mitochondrial-targeted agent developed to treat various hematologic and solid cancers.
Solasia acquired the rights to darinaparsin in March 2011 from Ziopharm Oncology, a Boston, MA-based biotechnology company specializing in cell-based therapies for cancer and graft-versus-host-disease (GvHD), for the potential treatment of peripheral T-cell lymphoma. The agent is currently in Phase II pivotal trials in Asia.
Process development and clinical manufacturing for the agent will begin in the fourth quarter of 2017 within Alcami’s new highly potent API suites, located at its API center of excellence facility in Germantown, WI.
“We are pleased to entrust Alcami with this project,” said Yoshihiro Arai, president and CEO of Solasia Pharma, in a company press release. “Finding a responsible partner for the development and manufacturing of our API was a significant step in our clinical program.”
"We are extremely grateful for the opportunity to partner with Solasia as the trusted supplier of darinaparsin. Our relationship is an excellent example of Alcami’s dedication to delivering reliable and high-quality medicines across the globe. As we continue to grow our established business in Japan, we look forward to supporting Solasia for its future clinical and commercial success,” stated Syed T. Husain, chief commercial officer of Alcami, in the company press release.